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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00625742 |
Condition | Intervention |
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Advanced Cancer Cachexia |
Behavioral: Graded Resistance Training Behavioral: Aerobic Exercise Drug: Melatonin Drug: Ibuprofen Drug: Atenolol Dietary Supplement: Juven |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Exploratory Trial of a Multimodal Treatment Strategy for Cancer Cachexia |
Estimated Enrollment: | 40 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven)
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Behavioral: Graded Resistance Training
Resistance training sessions twice weekly using Thera-bands.
Behavioral: Aerobic Exercise
Walking or running for 3-4 minutes at 70-80% of your maximum predicted heart rate.
Drug: Melatonin
20 mg PO Daily
Drug: Ibuprofen
400 mg PO Three Times Daily
Drug: Atenolol
25 mg PO daily if evidence of resting heart rate >110 b/min) or REE > 110% of predicted.
Dietary Supplement: Juven
90 calories of Juven, twice a day.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Egidio Del Fabbro, MD | 713-792-6085 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Egidio Del Fabbro, MD |
Principal Investigator: | Egidio Del Fabbro, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Egidio Del Fabbro, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0739 |
Study First Received: | February 19, 2008 |
Last Updated: | May 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00625742 History of Changes |
Health Authority: | United States: Institutional Review Board |
Advanced Cancer Cancer Cachexia Cachexia Atenolol Ibuprofen |
Melatonin Juven Exercise Training Weight Loss |
Anti-Inflammatory Agents Neurotransmitter Agents Antioxidants Adrenergic Agents Cachexia Body Weight Signs and Symptoms Weight Loss Body Weight Changes Adrenergic beta-Antagonists Melatonin Anti-Inflammatory Agents, Non-Steroidal Anti-Arrhythmia Agents |
Analgesics Ibuprofen Cyclooxygenase Inhibitors Central Nervous System Depressants Cardiovascular Agents Emaciation Antihypertensive Agents Analgesics, Non-Narcotic Adrenergic Antagonists Peripheral Nervous System Agents Atenolol Antirheumatic Agents |
Anti-Inflammatory Agents Neurotransmitter Agents Antioxidants Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cachexia Body Weight Signs and Symptoms Sensory System Agents Therapeutic Uses Weight Loss Body Weight Changes Adrenergic beta-Antagonists Melatonin |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Anti-Arrhythmia Agents Ibuprofen Sympatholytics Cyclooxygenase Inhibitors Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Emaciation Antihypertensive Agents Protective Agents Pharmacologic Actions Autonomic Agents Analgesics, Non-Narcotic |